WO2009002496A1 - Double row fixation system, medial row anchor placement system - Google Patents
Double row fixation system, medial row anchor placement system Download PDFInfo
- Publication number
- WO2009002496A1 WO2009002496A1 PCT/US2008/007856 US2008007856W WO2009002496A1 WO 2009002496 A1 WO2009002496 A1 WO 2009002496A1 US 2008007856 W US2008007856 W US 2008007856W WO 2009002496 A1 WO2009002496 A1 WO 2009002496A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- anchor
- slot
- tissue
- jaw member
- anchor slot
- Prior art date
Links
- 210000001519 tissue Anatomy 0.000 claims description 101
- 210000000988 bone and bone Anatomy 0.000 claims description 42
- 238000000034 method Methods 0.000 claims description 18
- 238000002604 ultrasonography Methods 0.000 claims description 8
- 238000003466 welding Methods 0.000 claims description 8
- 210000000513 rotator cuff Anatomy 0.000 claims description 4
- 239000000463 material Substances 0.000 description 15
- -1 polypropylene Polymers 0.000 description 5
- 229920000954 Polyglycolide Polymers 0.000 description 4
- 239000004633 polyglycolic acid Substances 0.000 description 4
- 229920004934 Dacron® Polymers 0.000 description 2
- 239000004677 Nylon Substances 0.000 description 2
- 239000004952 Polyamide Substances 0.000 description 2
- 239000004743 Polypropylene Substances 0.000 description 2
- 239000000560 biocompatible material Substances 0.000 description 2
- 229910052751 metal Inorganic materials 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- 229920001778 nylon Polymers 0.000 description 2
- 239000004033 plastic Substances 0.000 description 2
- 229920003023 plastic Polymers 0.000 description 2
- 229920002463 poly(p-dioxanone) polymer Polymers 0.000 description 2
- 229920002647 polyamide Polymers 0.000 description 2
- 239000000622 polydioxanone Substances 0.000 description 2
- 229920000728 polyester Polymers 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 229920001155 polypropylene Polymers 0.000 description 2
- 210000004872 soft tissue Anatomy 0.000 description 2
- 229910001220 stainless steel Inorganic materials 0.000 description 2
- 239000010935 stainless steel Substances 0.000 description 2
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 238000005553 drilling Methods 0.000 description 1
- 238000002674 endoscopic surgery Methods 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 210000004095 humeral head Anatomy 0.000 description 1
- 210000003041 ligament Anatomy 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 230000003287 optical effect Effects 0.000 description 1
- 239000005020 polyethylene terephthalate Substances 0.000 description 1
- 238000010079 rubber tapping Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000003356 suture material Substances 0.000 description 1
- 210000002435 tendon Anatomy 0.000 description 1
- 239000012815 thermoplastic material Substances 0.000 description 1
- 239000010936 titanium Substances 0.000 description 1
- 229910052719 titanium Inorganic materials 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0483—Hand-held instruments for holding sutures
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/28—Surgical forceps
- A61B17/2812—Surgical forceps with a single pivotal connection
- A61B17/282—Jaws
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
- A61B2017/00353—Surgical instruments, devices or methods for minimally invasive surgery one mechanical instrument performing multiple functions, e.g. cutting and grasping
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0409—Instruments for applying suture anchors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/044—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors with a threaded shaft, e.g. screws
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
- A61B2017/0496—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials for tensioning sutures
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/06166—Sutures
- A61B2017/0619—Sutures thermoplastic, e.g. for bonding, welding, fusing or cutting the suture by melting it
Definitions
- the top and bottom jaw members in an open position, define an area for receiving a portion of tissue, and the joint member articulates the jaw members from the open position to a tissue engaging position where the top and bottom jaw members grasp the portion of tissue;
- the first top anchor slot and first bottom anchor slot are adapted to receive a first anchor extending into the first top anchor slot, through the portion of tissue, and out of the first bottom anchor slot; and the second top anchor slot and second bottom anchor slot are adapted to receive a second anchor extending into the second top anchor slot, through the portion of tissue, and out of the second bottom anchor slot.
- first top anchor slot and second top anchor slot are positioned at points substantially equidistant from the proximal end of the top jaw member; and the first bottom anchor slot and second bottom anchor slot are positioned points substantially equidistant from the proximal end of the bottom jaw member.
- the suture welder further includes a tensioner adapted to apply tension to the suture portions.
- attaching the suture portions of the first and second anchors to each other includes tensioning the suture portions to secure the tissue to the bone.
- the energy includes thermal energy. In some embodiments, the energy includes heat energy.
- Fig. 2 is a top down view of the paddle grasped.
- Figs. 3A-3I illustrate the use of the paddle grasper to provide fixation of tissue to bone.
- Figs. 6A and 6B show an exemplary suture welder.
- grasper 100 includes top jaw member 102 and bottom jaw member 104 connected by joint member 106. Jaw members 102, 104 open to receive a portion of tissue 105, e.g., a portion of rotator cuff tissue in a shoulder.
- jaw members 102, 104 are flat, paddle type jaws. Jaw members 102, 104 each include a pair of anchor target slots 108. As described in further detail below, anchor target slots 108 can be used to easily and reliably provide desired positioning of suture anchors used to secure tissue 105 to bone 1 10.
- Paddle 100 may be constructed of any suitable material, e.g. biocompatible material including metal (e.g. stainless steel), plastic, polymers, and or other materials.
- Fig. 2 shows a top down view of grasper 100 positioned to grasp tissue 105.
- Anchor target slots 108 are formed as aligned pair of, e.g., semicircular apertures in the sides of the upper and lower jaw member paddles (Note that as used herein the term aperture indicates any open region through which a suture anchor may pass, any need not completely surround the anchor).
- the position of target anchors slots are chosen to correspond to a desired position for a pair of suture anchors 1 12. For example, as shown, target anchors slots 108 a placed such they are located a desired distance L from the edge of tissue 105 when the grasper has fully engaged the tissue. Accordingly, anchors 1 12 inserted at the target anchor locations will be placed at the correct distance medial the edge of tissue 105.
- anchor targets 108 are positioned distance W apart from each other on either side of jaw members 102, 104 Accordingly, anchors 122 inserted at the target anchor locations will be placed at the correct distance relative to each other.
- anchors 122 inserted at the target anchor locations will be placed at the correct distance relative to each other.
- other configurations may be used to provide any desired anchor placement.
- Figs. 3A-3I illustrate the use of grasper 100 to secure rotator cuff tissue 105 to adjacent humerous head bone 1 10.
- grasper 100 receives tissue 105 between jaw members 102, 104 such that bottom jaw member 104 is adjacent to bone 1 10.
- the grasper is advanced as far as possible in the medial direction, filling the area between jaw members 102, 104 with tissue to provide the desired tissue "bite.”
- a portion of tissue 105 is thereby grasped between jaw members 102, 104.
- Fig 3B shows a top down view of grasper 100 corresponding to the perspective view shown in Fig. 3A.
- suture anchors 1 12 are positioned over anchor target slots 108.
- FIG. 3E shows a top down view of grasper 100 corresponding to the perspective view shown in Fig. 3E. Arrows indicate the rotation of anchor 1 12 by driver 120 to auger through tissue 105 and thread into bone 1 10.
- any suitable jaw shape featuring and number of anchor target slots may be used.
- placement of the anchor target slots is determined by the desired positioning of the anchors to be implanted.
- grasper 100 is incorporated in endoscopic system 400.
- Endoscopic system 400 includes handle 402 with a controller 404.
- Stem 406 connects controller 404 to grasper 100, allowing an operator to articulate grasper 100 (e.g. to advance, retract, rotate, etc. grasper 100, or to articulate jaws 102, 104 to engage tissue 105).
- Grasper 100 and stem 406 are contained in a surgical cannula 408 or other tube which can be inserted into the patient through a small incision.
- endoscopic system 400 may include any of the various features or devices familiar in the art of endoscopic surgery.
- one suture anchor 1 12 includes an elongated rigid punch through portion 1 14 which extends along a longitudinal axis between end 1 19 and threaded tip end 1 16.
- End 1 19 includes a drive head (e.g. as shown a hexagonal drive head) for engagement with driver 120.
- End 1 16 includes a threaded portion 140 for auguring, boring, etc. through bone and tissue.
- the suture anchor 1 12 or parts thereof can be made of a bioresorbable material which will be resorbed after residing in a patient.
- the fused stitch is formed through a welding process in which portions of the suture segments are locally heated through the application of heat thereto until opposing portions melt. The melted portions are then pressed together in an overlapped joint and become fused.
- the joint includes a fused layer between and joining the first and second suture segments.
- the fused layer is fused material from the first and second suture segments and preferably is relatively thin and has a relatively large shear area compared to the suture segments.
- the suture welder 122 facilitates the creation of such a fused portion by maximizing contact between the suture segments during welding.
- the fused stitch produced by the suture welder 122 comprises one or more pieces of an elongated material, such as a surgical suture, or other material which is amenable to bonding through the application of heat thereto.
- Suitable materials for the elongated material include polymers, especially thermoplastic materials such as, for example, nylon (polyamide), polypropylene, DACRON ®. (polyester), polyglycolic acid (PGA), polyglyconate, and polydioxanone.
- the elongated material can be made of a single strand of a substantially monofilamentous material, or it can comprise multiple strands forming a single suture. The multi-strands can be twisted, braided or otherwise interlinked to increase the density, and thus the strength, of the composite strand.
- welder 122 may produce fused stitch 126 from suture portions 1 18 by applying other types of energy including ultrasound energy, radio frequency energy, chemical energy, optical energy, etc.
- the techniques and devices disclosed herein may be used to fixate any suitable tissue to bone, including, but not limited to, muscle tissue, tendons, and ligaments.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Molecular Biology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Rheumatology (AREA)
- Ophthalmology & Optometry (AREA)
- Surgical Instruments (AREA)
Abstract
An instrument is disclosed including: a top jaw member extending between a proximal end and a distal end and including a first top anchor target slot and a second top anchor target slot; a bottom jaw member extending between a proximal end and a distal end and including a first bottom anchor target slot and a second bottom anchor target slot; and a joint member connected to the proximal ends of the top jaw member and the bottom jaw member.
Description
DOUBLE ROW FIXATION SYSTEM. MEDIAL ROW ANCHOR
PLACEMENT SYSTEM
BACKGROUND
When soft tissue tears away from bone, reattachment becomes necessary. Various devices, including sutures alone, screws, staples, wedges, and plugs have been used in the past to secure soft tissue to bone.
Recently, various types of threaded suture anchors have been developed for this purpose. Some threaded suture anchors are designed to be inserted into a pre- drilled hole. Other suture anchors are self-tapping. In repair of tissue attachments to bone, e.g. in the shoulder, techniques have been developed that vastly increase the repaired tissue to bone area resulting in a repair that more closely replicates the original structure. These repair techniques are commonly referred to as "double row fixation" and includes the typical edge repair location as well as an additional "medial row" of fixation using an additional, medially located (relative to the edge repair) set of suture anchors to secure tissue to bone.
Correct placement of the additional tissue anchors medial to the edge repair is often critical to the success of this repair technique. If the medial anchors are placed too medial in relation to the first row (i.e. too far medially inward from the tissue edge) damage can occur to the humeral head. Additionally, the relative placement of anchors is important. If the anchors are placed too close or far apart from each other, the strength of the repair may not add value to the overall reconstruction at the repair site.
SUMMARY OF THE INVENTION
The inventors have realized that one may facilitate proper placement of suture anchors, e.g. medial row anchors in a "double row" repair. A "paddle style" grasper is structured to allow a desired depth of tissue bite while the width of the paddles are configured in such a way as to allow for fixation points to ideally spaced. With the grasper properly placed on the tissue, "punch through" suture
anchors are deployed at the at "anchor targets" on the grasper paddles. A "punch tip" on the anchors pierce the tissue grasped by the grasper and penetrate, e.g., thread into adjacent bone tissue. With the anchors properly placed the grasper is removed, and sutures from the two anchors are attached to one another forming, e.g. a mattress style stitch to secure the tissue to the bone.
In one aspect, an instrument is disclosed including: a top jaw member extending between a proximal end and a distal end and including a first top anchor target slot and a second top anchor target slot; a bottom jaw member extending between a proximal end and a distal end and including a first bottom anchor target slot and a second bottom anchor target slot; and a joint member connected to the proximal ends of the top jaw member and the bottom jaw member.
In some embodiments, the top and bottom jaw members, in an open position, define an area for receiving a portion of tissue, and the joint member articulates the jaw members from the open position to a tissue engaging position where the top and bottom jaw members grasp the portion of tissue.
In some embodiments, the jaw members are in the tissue engaging position, the first top anchor slot and first bottom anchor slot are adapted to receive a first anchor extending into the first top anchor slot, through the portion of tissue, and out of the first bottom anchor slot. In some embodiments, the jaw members are in the tissue engaging position, the second top anchor slot and second bottom anchor slot are adapted to receive a second anchor extending into the second top anchor slot, through the portion of tissue, and out of the second bottom anchor slot.
In some embodiments, the top jaw member and bottom jaw member each include a paddle extending along a longitudinal axis between the proximal end of the jaw member and the distal end of the jaw member, the paddle further extending along a transverse axis, transverse to the longitudinal axis, extending between a first side and a second side of the paddle.
In some embodiments, the first top anchor slot includes an aperture formed in the first side of the top jaw member paddle; the second top anchor slot includes an aperture formed in the second side of the top jaw member paddle; the first bottom anchor slot includes an aperture formed in the first side of the bottom jaw member
paddle; and the second bottom anchor slot includes an aperture formed in the second side of the bottom jaw member paddle.
In some embodiments, the first top anchor slot and second top anchor slot are positioned at points substantially equidistant from the proximal end of the top jaw member; and the first bottom anchor slot and second bottom anchor slot are positioned at points substantially equidistant from the proximal end of the bottom jaw member.
In some embodiments, when the jaw members are in the tissue engaging position, the first top anchor slot is substantially aligned with the first bottom anchor slot along an axis substantially orthogonal to the transverse and longitudinal axes of the top and bottom jaw member paddles, and the second top anchor slot is substantially aligned with the second bottom anchor slot along an axis substantially orthogonal to the transverse and longitudinal axes of the top and bottom jaw member paddles. In some embodiments, the tissue engaging position consists of the open position.
Some embodiments include an endoscopic assembly including a grasping instrument the type described above. The assembly further includes a handle; a controller mounted on the handle; and a stem operatively connecting the controller to the instrument to selectively articulate the jaw members.
Some embodiments include a surgical cannula surrounding at leas a portion of the stem or the instrument.
In another aspect, a surgical kit is disclosed including a first and a second suture anchor. Each anchor includes a rigid punch tip portion having a first end adapted to penetrate through tissue and into bone and second end; and a suture portion extending from the second end of the punch tip portion. The kit also includes a grasper including: a top jaw member extending between a proximal end and a distal end and including a first top anchor target slot and a second top anchor target slot; a bottom jaw member extending between a proximal end and a distal end and including a first bottom anchor target slot and a second bottom anchor target slot; a joint member connected to the proximal ends of the top jaw member and the bottom jaw member.
The top and bottom jaw members, in an open position, define an area for receiving a portion of tissue, and the joint member articulates the jaw members from the open position to a tissue engaging position where the top and bottom jaw members grasp the portion of tissue; When the jaw members are in the tissue engaging position, the first top anchor slot and first bottom anchor slot are adapted to receive a first anchor extending into the first top anchor slot, through the portion of tissue, and out of the first bottom anchor slot; and the second top anchor slot and second bottom anchor slot are adapted to receive a second anchor extending into the second top anchor slot, through the portion of tissue, and out of the second bottom anchor slot.
In some embodiments, the first top anchor slot includes an aperture formed in the first side of the top jaw member paddle; the second top anchor slot includes an aperture formed in the second side of the top jaw member paddle; the first bottom anchor slot includes an aperture formed in the first side of the bottom jaw member paddle; and the second bottom anchor slot includes an aperture formed in the second side of the bottom jaw member paddle.
In some embodiments, the first top anchor slot and second top anchor slot are positioned at points substantially equidistant from the proximal end of the top jaw member; and the first bottom anchor slot and second bottom anchor slot are positioned points substantially equidistant from the proximal end of the bottom jaw member.
In some embodiments, when the jaw members are in the tissue engaging position, the first top anchor slot is substantially aligned with the first bottom anchor slot along an axis substantially orthogonal to the transverse and longitudinal axes of the top and bottom jaw member paddles, and the second top anchor slot is substantially aligned with the second bottom anchor slot along an axis substantially orthogonal to the transverse and longitudinal axes of the top and bottom jaw member paddles.
In some embodiments the kit includes an anchor driver configured to engage the second end of the punch tip portion of at least one of the first and second anchors and drive the punch tip through tissue grasped by the grasper and into a portion bone located adjacent the bottom jaw member.
In some embodiments, the punch tip portion of each of the suture anchors includes a threaded tip, and the anchor driver is adapted to rotate and drive the at least one of the first and second anchors to bore into the portion of bone.
In some embodiments, the kit includes a suture welder including: a suture holding element adapted to receive the suture portions of the first and second suture anchors and place the suture portions in proximity to each other, a welding element adapted to apply energy to areas of the suture portions to at least partially fuse the suture portions to each other.
In some embodiments, the welding element includes a heater adapted to heat the suture portions.
In some embodiments, the welding element includes an ultrasound unit adapted to apply ultrasound energy to the areas of the suture portions to at least partially fuse the suture portions to each other.
In some embodiments, the suture welder further includes a tensioner adapted to apply tension to the suture portions.
In another aspect a method for securing a portion of tissue to an adjacent portion of bone is disclosed including providing a first and a second suture anchor each including a rigid punch tip portion having a first end adapted to penetrate through tissue and into bone and second end; a suture portion extending from the second end of the punch tip portion. The method includes providing a grasper including: a top jaw member extending between a proximal end and a distal end and including a first top anchor target slot and a second top anchor target slot; a bottom jaw member extending between a proximal end and a distal end and including a first bottom anchor target slot and a second top anchor target slot; a joint member connected to the proximal ends of the top jaw member and the bottom jaw member. The top and bottom jaw members, in an open position, define an area for receiving a portion of tissue, and the joint member articulates the jaw members from the open position to a tissue engaging position where the top and bottom jaw members grasp the portion of tissue.
The jaw members are in the tissue engaging position, the first top anchor slot and first bottom anchor slot are adapted to receive a first anchor extending into the first top anchor slot, through the portion of tissue, and out of the first bottom anchor slot. When the jaw members are in the tissue engaging position, the second top anchor slot and second bottom anchor slot are adapted to receive a second anchor extending into the second top anchor slot, through the portion of tissue, and out of the second bottom anchor slot.
The method further includes grasping the portion of tissue between the top and bottom jaw elements such that the bottom jaw element is adjacent the bone; positioning first and second anchors proximal the first and second top anchor slots, respectively; driving the punch tip portions of first and second anchors, respectively, through the first and second top anchor slot, through the tissue, through the first and second bottom anchor slots, and into the bone; removing the grasper; and attaching the suture portions of the first and second anchors to each other to secure the tissue to the bone.
In some embodiments attaching the suture portions of the first and second anchors to each other includes: placing the suture portions in proximity to each other; applying energy to the suture portions to at least partially fuse the suture portions to each other.
In some embodiments, attaching the suture portions of the first and second anchors to each other includes tensioning the suture portions to secure the tissue to the bone.
In some embodiments, the energy includes thermal energy. In some embodiments, the energy includes heat energy.
In some embodiments, the tissue includes a portion of a rotator cuff. In some embodiments, the bone includes a portion of a humerous bone head. Various embodiments may include any of the features described above, alone or in combination.
BRIEF DESCRIPTION OF THE DRAWINGS
The foregoing will be apparent from the following more particular description of example embodiments of the invention, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating embodiments of the present invention.
Fig. 1 is a perspective view of a paddle grasper.
Fig. 2 is a top down view of the paddle grasped.
Figs. 3A-3I illustrate the use of the paddle grasper to provide fixation of tissue to bone.
Fig. 4 is a schematic of an endoscopic system featuring the paddle grasper.
Fig. 5 shows an exemplary suture anchor.
Figs. 6A and 6B show an exemplary suture welder.
DETAILED DESCRIPTION
Referring to Fig. 1, grasper 100 includes top jaw member 102 and bottom jaw member 104 connected by joint member 106. Jaw members 102, 104 open to receive a portion of tissue 105, e.g., a portion of rotator cuff tissue in a shoulder.
Joint member 106 allows jaw members 102, 104 to engage and grasp the tissue located therebetween (e.g. by articulating jaws 102, 104 from an open position to a closed position, or simply by providing mechanical resistance as tissue is received between the jaw members).
As shown, the jaw members 102, 104 are flat, paddle type jaws. Jaw members 102, 104 each include a pair of anchor target slots 108. As described in further detail below, anchor target slots 108 can be used to easily and reliably provide desired positioning of suture anchors used to secure tissue 105 to bone 1 10. Paddle 100 may be constructed of any suitable material, e.g. biocompatible material including metal (e.g. stainless steel), plastic, polymers, and or other materials. Fig. 2 shows a top down view of grasper 100 positioned to grasp tissue 105.
Anchor target slots 108 are formed as aligned pair of, e.g., semicircular apertures in the sides of the upper and lower jaw member paddles (Note that as used herein the
term aperture indicates any open region through which a suture anchor may pass, any need not completely surround the anchor). The position of target anchors slots are chosen to correspond to a desired position for a pair of suture anchors 1 12. For example, as shown, target anchors slots 108 a placed such they are located a desired distance L from the edge of tissue 105 when the grasper has fully engaged the tissue. Accordingly, anchors 1 12 inserted at the target anchor locations will be placed at the correct distance medial the edge of tissue 105. Further anchor targets 108 are positioned distance W apart from each other on either side of jaw members 102, 104 Accordingly, anchors 122 inserted at the target anchor locations will be placed at the correct distance relative to each other. Of course, it is to be understood that other configurations may be used to provide any desired anchor placement.
Figs. 3A-3I illustrate the use of grasper 100 to secure rotator cuff tissue 105 to adjacent humerous head bone 1 10. Referring to Fig. 3 A, grasper 100 receives tissue 105 between jaw members 102, 104 such that bottom jaw member 104 is adjacent to bone 1 10. The grasper is advanced as far as possible in the medial direction, filling the area between jaw members 102, 104 with tissue to provide the desired tissue "bite." A portion of tissue 105 is thereby grasped between jaw members 102, 104. Fig 3B shows a top down view of grasper 100 corresponding to the perspective view shown in Fig. 3A. Referring to Fig. 3C, suture anchors 1 12 are positioned over anchor target slots 108. Suture anchors 112 each include a rigid (e.g. metal or rigid plastic) punch through portion 1 14 with a threaded tip 1 16 . A flexible suture portion 1 18 extends from the end 1 19 of punch through portion 1 14 opposite threaded tip 1 16. Suture portions 1 18 may be made from any suitable suture material, including weldable (e.g. heat- or ultrasound- weldable) material. The ends 1 19 of punch through portions 1 14 are engaged by anchor drivers 120 (e.g. manual screw anchor driver, motorized anchor driver, etc.). Figure 3D shows a top down view of grasper 100 corresponding to the perspective view shown in Fig. 3C.
Referring to Fig. 3E, drivers 120 have been used to drive anchors 1 12 through tissue 105 and into bone 1 10, such that the rigid punch through portions 1 16 have penetrated (e.g. bored, treaded, augured, etc) into bone 1 10. Flexible suture portions 1 12 extend from the ends 1 19 of punch through portions 1 19 out
through tissue 105. In the interest of clarity, anchor drivers 120 are not shown, but remain engaged with ends 1 19. In some embodiments, the driving of anchors 1 12 may be preceded by pre-drilling step when a drill is used to provide a guide hole into the tissue and bone. Figure 3F shows a top down view of grasper 100 corresponding to the perspective view shown in Fig. 3E. Arrows indicate the rotation of anchor 1 12 by driver 120 to auger through tissue 105 and thread into bone 1 10.
Referring to Fig. 3G, grasper 100 has been removed, and anchor drivers 120 withdrawn from the treatment area. Punch through portions 1 14 of anchors 1 12 are securely anchored at the desired position (both relative to tissue 105 and each to each other) in bone 1 10. Flexible suture portions 1 18 extend from ends 1 19 of punch through portions 1 14, passing out through tissue 105.
Referring to Figure 3H, suture welder 122 engages flexible suture portions 1 18 extending from tissue 105. Welder 122 captures suture portions 1 18 in between welder jaws 124. Suture portions 1 18 are tensioned to secure tissue 105 to bone 1 10 (e.g. with a mattress style stitch or other suitable stitch known in the art). Welder 122 brings areas of flexible suture portions 1 18 into proximity with each other and applies energy (e.g. heat energy from a heating element, ultrasound energy from a ultrasound transducer, etc.) to fuse the areas together, thereby forming a knotless suture stitch connecting anchors 1 12 to each other to secure tissue 105 to bone 1 10. For example, tensioner 123 may apply tension in opposing directions to suture portions 1 18 (as indicated by dark arrows). It is to be understood that any other suitable technique for attaching anchors 1 12 may be used, including, for example, performing a conventional knotted stitch with flexible suture portions 1 18. In various embodiments, welder 122 may be any suitable welder, e.g. of the types available from Axya Medical, Inc. of Beverly, Massachusetts, including those described in, U.S. Patent No. 7,090,1 1 1, issued August 16, 2006, U.S. Patent No. 6,923,824, issued August 2, 2005, U.S. Patent No. 6,669,705, issued December 30, 2003, U.S. Patent No. 6,666,877, issued December 23, 2003, Patent No. 6,409,743, issued June 25, 2002, U.S. Patent No. 6,358,271 , issued March 19, 2002, U.S. Patent No. 6,286,746, issued September 1 1, 2001, U.S. Patent No. 6,217,591 , issued April 17, 2001 , U.S. Patent No, 6,174,324, issued January 16, 2001 , U.S. Patent No.
6,106,545, issued August 22, 2000, U.S. Patent No. 6,056,751, issued May 2, 2000, U.S. Patent No. 5,964,765, issued October 12, 1999, and U.S. Patent No. 5,893,880, issued April 13, 1999 the contents of each of which are incorporated by reference herein in their entirety. Fig. 31 shows welder 122 retracted from the area after the formation of knotless stitch 126. Note that by employing grasper 120, proper placement of anchors 1 12 was easily accomplished. The above steps may be repeated to deliver additional anchors.
Note that while the above examples show a grasper 100 featuring paddle type jaw members 102, 014 each having a pair of anchor target slots 108, any suitable jaw shape featuring and number of anchor target slots may be used. For a given embodiment, placement of the anchor target slots is determined by the desired positioning of the anchors to be implanted.
Referring to Fig. 4, in some embodiments grasper 100 is incorporated in endoscopic system 400. Endoscopic system 400 includes handle 402 with a controller 404. Stem 406 connects controller 404 to grasper 100, allowing an operator to articulate grasper 100 (e.g. to advance, retract, rotate, etc. grasper 100, or to articulate jaws 102, 104 to engage tissue 105). Grasper 100 and stem 406 are contained in a surgical cannula 408 or other tube which can be inserted into the patient through a small incision. In various embodiments, endoscopic system 400 may include any of the various features or devices familiar in the art of endoscopic surgery.
As illustrated in FIG. 5, in one embodiment, one suture anchor 1 12 includes an elongated rigid punch through portion 1 14 which extends along a longitudinal axis between end 1 19 and threaded tip end 1 16. End 1 19 includes a drive head (e.g. as shown a hexagonal drive head) for engagement with driver 120. End 1 16 includes a threaded portion 140 for auguring, boring, etc. through bone and tissue.
Anchor 1 12 includes flexible suture portion 1 18 extending from end 1 19, and secured to punch through portion 1 14. Suture portion 118 may be made of a material amenable to bonding through the application of heat or energy thereto such as, for example, nylon (polyamide), polypropylene, Dacron ©(polyester), polyglycolic acid (PGA), polyglyconate, and polydioxanone. In some embodiments,
rigid punch through portion 1 14 may also be made of such material. In such cases portion 1 14 may be bonded to portion 1 18 by the application by the application of heat or other energy (e.g. ultrasound energy). Other suitable methods of bonding can be used if for example, portion 1 14 is made of another material, such as stainless steel, titanium, or some other durable, non-degradable, biocompatible material.
The suture anchor 1 12 or parts thereof can be made of a bioresorbable material which will be resorbed after residing in a patient.
FIGs. 6A and 6B show an embodiment of suture welder 122 for creating fused stitch. The suture welder 122 includes a jaw assembly 618 having a first jaw 620 for receiving a first suture segment 622 in recess 640, and a second jaw 624 for receiving a second suture segment 626 in recess 640 so that the second suture segment is adjacent the first suture segment. The suture welder 122 also includes a heater element 612 positioned between the suture segments 622, 626. The heater element 612 is adapted to melt at least adjacent surfaces of the overlapping first and second suture segments 622, 626. Once melted, the suture segments 622, 626 can be pressed together by the jaws 620, 624 and allowed to cool to form a fused layer 28 to secure the suture segments 622, 626 together.
The suture welder 122 beneficially provides a fused stitch 14 an elongated material, such as a surgical suture 616, wherein the stitch has at least comparable strength to knotted stitches or loops closed by other means. The fused stitch gains its comparable strength from the properties of the fused layer of the stitch, as detailed more fully in U.S. Pat. No. 5,893,880, which is assigned to the assignee of the present disclosure and incorporated herein by reference.
In particular, the fused stitch is formed through a welding process in which portions of the suture segments are locally heated through the application of heat thereto until opposing portions melt. The melted portions are then pressed together in an overlapped joint and become fused. The joint includes a fused layer between and joining the first and second suture segments. The fused layer is fused material from the first and second suture segments and preferably is relatively thin and has a relatively large shear area compared to the suture segments. In some embodiments, the suture welder 122 facilitates the creation of such a fused portion by maximizing contact between the suture segments during welding.
The fused stitch produced by the suture welder 122 comprises one or more pieces of an elongated material, such as a surgical suture, or other material which is amenable to bonding through the application of heat thereto. Suitable materials for the elongated material include polymers, especially thermoplastic materials such as, for example, nylon (polyamide), polypropylene, DACRON ®. (polyester), polyglycolic acid (PGA), polyglyconate, and polydioxanone. The elongated material can be made of a single strand of a substantially monofilamentous material, or it can comprise multiple strands forming a single suture. The multi-strands can be twisted, braided or otherwise interlinked to increase the density, and thus the strength, of the composite strand.
As noted above, in some embodiments, welder 122 may produce fused stitch 126 from suture portions 1 18 by applying other types of energy including ultrasound energy, radio frequency energy, chemical energy, optical energy, etc.
The techniques and devices disclosed herein may be used to fixate any suitable tissue to bone, including, but not limited to, muscle tissue, tendons, and ligaments.
The techniques and devices disclosed above may be used in treating human patients, veterinary patients, etc.
In the event that any technical definitions presented in this application conflict with any documents incorporated by reference, the definition found in the present application should be understood to hold.
While particular examples have been provided above, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the claims.
Claims
1. An instrument comprising: a top jaw member extending between a proximal end and a distal end and comprising a first top anchor target slot and a second top anchor target slot; a bottom jaw member extending between a proximal end and a distal end and comprising a first bottom anchor target slot and a second bottom anchor target slot; and a joint member connected to the proximal ends of the top jaw member and the bottom jaw member; wherein the top and bottom jaw members, in an open position, define an area for receiving a portion of tissue, and the joint member articulates the jaw members from the open position to a tissue engaging position wherein the top and bottom jaw members grasp the portion of tissue; wherein, when the jaw members are in the tissue engaging position, the first top anchor slot and first bottom anchor slot are adapted to receive a first anchor extending into the first top anchor slot, through the portion of tissue, and out of the first bottom anchor slot; and wherein, when the jaw members are in the tissue engaging position, the second top anchor slot and second bottom anchor slot are adapted to receive a second anchor extending into the second top anchor slot, through the portion of tissue, and out of the second bottom anchor slot.
2. The instrument of claim 1 , wherein the top jaw member and bottom jaw member each comprise a paddle extending along a longitudinal axis between the proximal end of the jaw member and the distal end of the jaw member, said paddle further extending along a transverse axis, transverse to said longitudinal axis, extending between a first side and a second side of the paddle.
3. The instrument of claim 2, wherein: the first top anchor slot comprises an aperture formed in the first side of the top jaw member paddle; the second top anchor slot comprises an aperture formed in the second side of the top jaw member paddle; the first bottom anchor slot comprises an aperture formed in the first side of the bottom jaw member paddle; and the second bottom anchor slot comprises an aperture formed in the second side of the bottom jaw member paddle.
4. The instrument of claim 3, wherein: the first top anchor slot and second top anchor slot are positioned at points substantially equidistant from the proximal end of the top jaw member; and the first bottom anchor slot and second bottom anchor slot are positioned at points substantially equidistant from the proximal end of the bottom jaw member.
5. The instrument of claim 4, wherein, when the jaw members are in the tissue engaging position; the first top anchor slot is substantially aligned with the first bottom anchor slot along an axis substantially orthogonal to the transverse and longitudinal axes of the top and bottom jaw member paddles; and the second top anchor slot is substantially aligned with the second bottom anchor slot along an axis substantially orthogonal to the transverse and longitudinal axes of the top and bottom jaw member paddles.
6. The instrument of claim 1, wherein the tissue engaging position consists of the open position.
7. An endoscopic assembly including the instrument of claim 1 , and further comprising: a handle; a controller mounted on the handle; a stem operatively connecting the controller to the instrument to selectively articulate the jaw members.
8. The endoscopic assembly of claim 7, further comprising a surgical cannula surrounding at leas a portion of the stem or the instrument.
9. A surgical kit comprising: a first and a second suture anchor each comprising: a rigid punch tip portion having a first end adapted to penetrate through tissue and into bone and second end; a suture portion extending from the second end of the punch tip portion; and a grasper comprising: a top jaw member extending between a proximal end and a distal end and comprising a first top anchor target slot and a second top anchor target slot; a bottom jaw member extending between a proximal end and a distal end and comprising a first bottom anchor target slot and a second bottom anchor target slot; a joint member connected to the proximal ends of the top jaw member and the bottom jaw member; wherein the top and bottom jaw members, in an open position, define an area for receiving a portion of tissue, and the joint member articulates the jaw members from the open position to a tissue engaging position wherein the top and bottom jaw members grasp the portion of tissue; wherein, when the jaw members are in the tissue engaging position, the first top anchor slot and first bottom anchor slot are adapted to receive a first anchor extending into the first top anchor slot, through the portion of tissue, and out of the first bottom anchor slot; and wherein, when the jaw members are in the tissue engaging position, the second top anchor slot and second bottom anchor slot are adapted to receive a second anchor extending into the second top anchor slot, through the portion of tissue, and out of the second bottom anchor slot.
10. The kit of claim 9, wherein: the first top anchor slot comprises an aperture formed in the first side of the top jaw member paddle; the second top anchor slot comprises an aperture formed in the second side of the top jaw member paddle; the first bottom anchor slot comprises an aperture formed in the first side of the bottom jaw member paddle; and the second bottom anchor slot comprises an aperture formed in the second side of the bottom jaw member paddle.
1 1. The kit of claim 10, wherein: the first top anchor slot and second top anchor slot are positioned at points substantially equidistant from the proximal end of the top jaw member; and the first bottom anchor slot and second bottom anchor slot are positioned points substantially equidistant from the proximal end of the bottom jaw member.
12. The kit of claim 1 1 , wherein, when the jaw members are in the tissue engaging position,: the first top anchor slot is substantially aligned with the first bottom anchor slot along an axis substantially orthogonal to the transverse and longitudinal axes of the top and bottom jaw member paddles, and the second top anchor slot is substantially aligned with the second bottom anchor slot along an axis substantially orthogonal to the transverse and longitudinal axes of the top and bottom jaw member paddles.
13. The surgical kit of claim 9, further comprising: an anchor driver configured to engage the second end of the punch tip portion of at least one of the first and second anchors and drive said punch tip through tissue grasped by the grasper and into a portion bone located adjacent the bottom jaw member.
14. The surgical kit of claim 13, wherein the punch tip portion of each of the suture anchors comprises a threaded tip, and the anchor driver is adapted to rotate and drive the at least one of the first and second anchors to bore into the portion of bone.
15. The surgical kit of claim 13, further comprising a suture welder comprising: a suture holding element adapted to receive the suture portions of the first and second suture anchors and place said suture portions in proximity to each other; and a welding element adapted to apply energy to areas of the suture portions to at least partially fuse the suture portions to each other.
16. The surgical kit of claim 15, wherein the welding element comprises a heater adapted to heat the suture portions.
17. The surgical kit of claim 15, wherein the welding element comprises an ultrasound unit adapted to apply ultrasound energy to the areas of the suture portions to at least partially fuse the suture portions to each other.
18. The surgical kit of claim 12, wherein the suture welder further comprises a tensioner adapted to apply tension to the suture portions.
19. A surgical method for securing a portion of tissue to an adjacent portion of bone comprising: providing a first and a second suture anchor each comprising: a rigid punch tip portion having a first end adapted to penetrate through tissue and into bone and second end; a suture portion extending from the second end of the punch tip portion; and providing a grasper comprising: a top jaw member extending between a proximal end and a distal end and comprising a first top anchor target slot and a second top anchor target slot; a bottom jaw member extending between a proximal end and a distal end and comprising a first bottom anchor target slot and a second top anchor target slot; a joint member connected to the proximal ends of the top jaw member and the bottom jaw member; wherein the top and bottom jaw members, in an open position, define an area for receiving a portion of tissue, and the joint member articulates the jaw members from the open position to a tissue engaging position wherein the top and bottom jaw members grasp the portion of tissue; wherein, when the jaw members are in the tissue engaging position, the first top anchor slot and first bottom anchor slot are adapted to receive a first anchor extending into the first top anchor slot, through the portion of tissue, and out of the first bottom anchor slot; and wherein, when the jaw members are in the tissue engaging position, the second top anchor slot and second bottom anchor slot are adapted to receive a second anchor extending into the second top anchor slot, through the portion of tissue, and out of the second bottom anchor slot; grasping the portion of tissue between the top and bottom jaw elements such that the bottom jaw element is adjacent the bone; positioning first and second anchors proximal the first and second top anchor slots, respectively; driving the punch tip portions of first and second anchors, respectively, through the first and second top anchor slot, through the tissue, through the first and second bottom anchor slots, and into the bone; removing the grasper; and attaching the suture portions of the first and second anchors to each other to secure the tissue to the bone.
20. The method of claim 19, wherein attaching the suture portions of the first and second anchors to each other comprises: placing the suture portions in proximity to each other; and applying energy to the suture portions to at least partially fuse the suture portions to each other.
21. The method of claim 20, wherein attaching the suture portions of the first and second anchors to each other comprises tensioning the suture portions to secure the tissue to the bone.
22. The method of claim 20, wherein the energy comprises thermal energy.
23. The method of claim 20, wherein the energy comprises heat energy.
24. The method of claim 19, wherein the tissue comprises a portion of a rotator cuff.
25. The method of claim 24, wherein the bone comprises a portion of a humerous skeletal bone head.
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